AAT + Corticosteroids for Graft-versus-Host Disease
Trial Summary
What is the purpose of this trial?
Study CSL964_5001 will investigate the efficacy of AAT with corticosteroids compared with corticosteroids alone as first line therapy for patients with high-risk acute GVHD
Research Team
Study Director
Principal Investigator
CSL Behring
Eligibility Criteria
This trial is for patients aged 12 or older who have acute GVHD after a stem cell transplant and need systemic therapy with corticosteroids. It's not for those previously treated with AAT, having cancer that's returned or not responding to treatment, using steroids within the last week before GVHD onset, or currently on other drugs for GVHD.Inclusion Criteria
Exclusion Criteria
Treatment Details
Interventions
- Alpha-1 antitrypsin (AAT)
- Placebo
Alpha-1 antitrypsin (AAT) is already approved in United States, European Union for the following indications:
- Chronic obstructive pulmonary disease (COPD) associated with alpha-1 antitrypsin deficiency
- Chronic obstructive pulmonary disease (COPD) associated with alpha-1 antitrypsin deficiency
Find a Clinic Near You
Who Is Running the Clinical Trial?
CSL Behring
Lead Sponsor
Dr. Paul McKenzie
CSL Behring
Chief Executive Officer since 2023
PhD in Chemical Engineering from Carnegie Mellon University, B.S. in Chemical Engineering from the University of Pennsylvania
Dr. Bill Mezzanotte
CSL Behring
Chief Medical Officer since 2021
MD from Duke University
National Institutes of Health (NIH)
Collaborator
National Cancer Institute (NCI)
Collaborator
Blood and Marrow Transplant Clinical Trials Network
Collaborator
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator